IMPAACT P1093 is an ongoing Phase I/II multicenter, open-label, pharmacokinetic (PK), safety, dose finding study of dolutegravir (DTG) plus optimized background regimen (OBR) in children and adolescents in age defined cohorts. The pediatric weight band dosing of ~1 mg/kg once a day in adolescents achieved PK exposure comparable to those observed at 50 mg once daily in adults.

Cohort IIA enrolled HIV infected treatment experienced, integrase naive children >6 to <12 years of age with an HIV RNA of ≥1000 copies/mL (c/mL) into Stage 1 (intensive PK) or Stage 2 (no PK, safety and efficacy). In Stage 1, DTG was added to a stable, failing ARV regimen, with OBR optimization after intensive PK (~Day 5-10); in Stage 2, DTG and OBR at study entry. Safety, tolerability, CD4 cell count and HIV-1 RNA were evaluated at Week 48,a primary objective. Virologic success was defined as achieving an HIV-1 RNA <400 c/mL by Week 48 based on the FDA snapshot algorithm and HIV-1 RNA <50 c/mL as a secondary outcome.